Court decisions can’t create certainty because they’re limited to the facts of each case

Second, why are there judicially-created exceptions in the first place? If the United States Government decides not to issue patents to certain types of creations that would otherwise fall within the four statutory categories, such as diagnostic techniques, it is up to Congress to consider, debate, and decide what those exclusions are. Courts are not well-suited to consider what are fundamentally major policy issues. The Constitution binds the Judiciary to hearing cases and controversies.30 As such, courts must take cases as they come, and decisions must be limited to the facts and issues at-hand. This is not conducive to crafting broad patent policy and providing certainty to industry. In addition, decisions in one case as to whether an invention falls in or out of a judicial exception leaves future applicants, litigants, and courts to guess how the exception might apply to their inventions, which are often very different from the precedent.

This leads to the third part of the problem: The judicially-created exemptions are confusing. The guessing game of how to apply these decisions to other inventions leads to distorted legal outcomes and significant uncertainty. For example, in Athena Diagnostics v. Mayo Collaborative Services, the panel majority held that medical diagnostic methods for “diagnosing neurological disorders” are not patent eligible because they “are directed to a natural law and lack an inventive concept.”31 The panel majority reached this holding despite acknowledging that “Congress intended statutory subject matter to include anything under the sun that is made by man.”32 This is because the panel majority felt bound by the Supreme Court’s exception analysis of an entirely different invention in Mayo Collaborative Services v. Prometheus Laboratories33 (referred to as the Mayo/Alice framework by practitioners), stating: “[W]hether or not we as individual judges might agree or not that these claims only recite a natural law, the Supreme Court has effectively told us in Mayo that correlations between the presence of a biological material and a disease are laws of nature.”34 Various judges in four dissents to a denial of rehearing en banc voiced dismay over the confusing nature of the judge-made exceptions. The common theme amongst the dissents was the idea that one Supreme court decision—in this case, Mayo—could not be read so “broadly” to preclude any and all types of diagnostic methods that the Supreme Court inherently could not have considered in merely one case and controversy involving a separate patent.35 As Chief Judge Moore observed, however, the fact is that, “[s]ince Mayo, we have held every single diagnostic claim in every case before us ineligible.”36 Indeed, the Chief Judge said, “[w]e have turned Mayo into a per se rule that diagnostic kits and techniques are ineligible.”37

Cases like Athena Diagnostics and the Mayo/Alice framework are indicative of the problem of essentially crafting patent policy through the Judiciary. Entire industries like the medical diagnostics industry—which is incredibly important to medical sciences and human health—are thrown into a state of confusion. Research and development and investment decisions are stymied because inventors and investors alike do not know whether they will receive the patent protections that Madison found as vital to the strength of our nation and our economy. Investments in other cutting-edge technologies like 5G, blockchain, and artificial intelligence (to name a few) also are threatened for this same reason. To be precise: if the United States is to deny patents to entire categories of invention, such as “diagnostic kits and techniques,” this is a decision that Congress must debate and decide.